Gluten Free Watchdog Comments on Citizen Petition on Gluten Labeling of MedicationsTricia Thompson
As many of you know H.R. 3648: Gluten in Medicine Disclosure Act of 2015 was introduced last fall. The full title of this bill is, “To amend the Federal Food, Drug, and Cosmetic Act to require the label of drugs intended for human use to contain a parenthetical statement identifying the source of any ingredient constituting or derived from a grain or starch-containing ingredient.” An earlier version of this bill was introduced in 2013. According to govtrack.com this bill has 0% of chance of being enacted. For details see https://www.govtrack.us/congress/bills/114/hr3648
As many of you also know a citizen petition was filed in 2008 to exclude the use of wheat gluten in prescription and OTC drugs. It took FDA seven years to respond to this petition. A new petition was filed at the end of 2015 requesting that medications disclose when gluten is present in excess of 20 ppm gluten and/or when medications do not meet the conditions of the finalized (currently proposed) FDA rule “Gluten-Free Labeling of Fermented or Hydrolyzed Foods.
Please make your voice heard on this issue. To read the petition and to comment go to http://www.regulations.gov/#!documentDetail;D=FDA-2015-P-5081-0002 The petition is listed under “primary documents.” Upload your comments by clicking “comment now.”
I will be posting comments soon. A draft of my comments is pasted below.
Comments submitted by Tricia Thompson, MS, RD
Founder, Gluten Free Watchdog, LLC
In response to Docket Number FDA-2015-P-5081
This comment concerns citizen petition FDA-2015-P-5081 requesting that the FDA Commissioner create a regulation in the form of a mandatory rule: that medications disclose when gluten is present in excess of 20 ppm gluten and/or when medications do not meet the conditions of the finalized (currently proposed) FDA rule “Gluten-Free Labeling of Fermented or Hydrolyzed Foods.”
While the Agency considers its response to the current request, please keep in mind that the study commissioned by FDA and cited in the Agency’s response to another citizen petition on the issue of gluten in medications (FDA-2008-P-0333 citizen petition to remove gluten ingredients from medications) appears to be flawed.
“39. FDA funded a study recently completed by the National Foundation for Celiac Awareness (NFCA) in which 39 drugs were tested for gluten.”
http://www.regulations.gov/#!documentDetail;D=FDA-2008-P-0333-0030 (see bottom of page 18).*
The study cited above appears to have flaws that I and others discussed at length with the lead authors after the study was first posted on the NFCA website in 2014. It was revised in May 2015. The May version is currently posted on the Beyond Celiac (formerly known as NFCA) website. At issue is the apparent belief of the authors that the part per million gluten contamination value changes based on medication dosage. As FDA knows, ppm is a proportion/percentage. One pill, 1/2 pill, or the entire bottle has the same ppm value. What obviously changes based on dosage and ppm contamination level is the milligram amount of gluten ingested.
The study authors’ apparent confusion regarding parts per million is illustrated in the following passage from the study http://www.beyondceliac.org/SiteData/docs/PublicRepo/9180ed94e35ad91f/Public%20Report_revised_5_2015.pdf (see page 17):
“Testing Methods: Four drugs (esomeprazole capsules, tramadol tablets, diphenhydramine HCL tablets and chlorthalidone tablets) tested positive in the Competitive ELISA when their gluten concentrations were examined in raw form. Since the Competitive assay protocol required taking 1000 mg of sample, we had to use 4.58 tablets for esomeprazole, 4 tablets for tramadol, 3.88 tablets for diphenhydramine and 7.09 tablets for chlorthalidone for the assay. Adjusting the assay result for a subsample of 1 tablet/capsule resulted in the ppm for these drugs to be below 10ppm, the level of quantification. For this reason, we are reporting that these drugs tested below the LOQ, and therefore negative for gluten.”
On page 18 of FDA’s response to Mr. Weber (FDA-2008-P-0333) the following is written:
“3. Overall Conclusion Regarding Quantities of Gluten in Oral Drug Products We recognize there is some uncertainty in our analysis regarding quantities of gluten potentially present in oral drug products. But we believe based on this analysis that oral drug products marketed in the United States today- apart from exceedingly rare oral drug products that contain and should be labeled as containing wheat gluten as an ingredient- are very unlikely to contain more than 0.5 mg gluten per unit dose. 39”
(Note: 39 is the reference cited above—the study FDA commissioned from NFCA).
FDA may very well be correct in its conclusion that medications are unlikely to contain more than 0.5 mg gluten per unit dose but this conclusion must be based on accurate testing data.
In the interest of transparency, as part of the Agency’s response to this particular citizen petition (FDA-2015-P-5081), please release what the authors of the FDA commissioned study term “raw “ part per million test results for all drugs tested. This would be the ppm gluten result before the researchers appear to have erroneously recalculated the ppm amount based on dosage size.
Tricia Thompson, MS, RD
* In 2011, the Food and Drug Administration (FDA) awarded Beyond Celiac (formerly known as the National Foundation for Celiac Awareness) a grant to study gluten in medications. Beyond Celiac assembled a team of researchers who conducted the study and developed the report under the leadership of Loretta Jay, MA, Parasol LLC, and Robert A. Mangione, RPh, EdD Provost and Professor, St. John’s University.
Thank you for keeping such a close eye on this issue, and this research. It still surprises me how many researchers seem unable to grasp the necessary mathematics involved. 🙁
Truly frustrating especially after spending hours on the phone trying to explain it to them.
It amazes me that the FOOD and DRUG Administration does not regulate top 8 allergens in drugs the same way it regulates them in foods…
The lack of documentation and my trust that all RX’s were safe just about killed me…or truly made me very very sick and no one could figure out why. I knew that I had not cross contaminated myself. My pharmacist now checks every RX and manufacturer before she fills my medications. My doctor was furious and even contacted the pharmaceutical company on my behalf!
“very unlikely to contain more than 0.5 mg gluten per unit dose”
So kind of like Russian Roulette.